Pubdate: Wed, 9 Oct 2002 Source: Ottawa Citizen (CN ON) 05D} Copyright: 2002 The Ottawa Citizen Contact: http://www.canada.com/ottawa/ottawacitizen/ Details: http://www.mapinc.org/media/326 Author: Helen Branswell FIRST CANADIAN TRIAL OF MEDICINAL MARIJUANA FOR HIV/AIDS PATIENTS STARTS TORONTO (CP) - Will marijuana-induced munchies help people with HIV and AIDS combat nausea and avoid the weight-loss that the disease brings on? Researchers in Toronto are hoping to find out. Canada's first government-sponsored trial of medicinal marijuana in HIV/AIDS officially started on Wednesday, led by researchers from St. Michael's Hospital and the Community Research Initiative of Toronto. "I think the time is right to look at this," said principal investigator Dr. Kevin Gough, medical director of HIV services at the hospital. "Let's find out what role, if any, that smoked cannabis has in, not only HIV and AIDS, but other medical illnesses as well." Advocates of medicinal marijuana believe the drug can be useful for a wide range of conditions. Anecdotal evidence suggests it helps in pain control, curbs nausea brought on by chemotherapy or HIV/AIDS drugs, and stimulates the appetite of people who have lost interest in eating as a result of their conditions or medications. But anecdotal evidence doesn't cut it when you are asking a government to allow large numbers of ill people to buy and smoke what is still an illegal substance. So Health Canada has authorized research to gather clinical evidence that may have implications for Canadian policy, and that will likely be scrutinized by governments outside Canada as well. The current study is a pilot to gather information that will be used to design a larger, multi-centre clinical trial. The pilot phase, involving 32 participants with HIV/AIDS, is expected to last about a year. All participants will have smoked marijuana before. Because there is little consensus on any risks associated with marijuana use, researchers can't ethically ask people to take the drug for the first time for a study. But only people who haven't used the drug in the previous 30 days will be eligible to take part. That's to ensure there are no lingering effects of non-study marijuana in their systems. Over a two-month period, each participant will be given three supplies of varying strengths of marijuana plus a placebo. They will be asked to use each for a period of one week and will not be informed which is which. Throughout the study they will keep a diary detailing how much they smoked, how they felt, and how much and what they ate. After using one strength for a week, they will be asked to go a week without smoking marijuana, to cleanse the drug from their systems. Participants will be barred from using non-study marijuana during the trial and will be tested to ensure they are honouring that rule. Street marijuana contains compounds not found in study-grade marijuana, Gough explained. Although Canada is in the process of developing its own supply of study-grade marijuana, the crop - being grown in an underground facility in Manitoba - isn't ready for use. The marijuana for this study comes from the U.S. National Institute of Drug Abuse, currently the only producer of research-grade marijuana in North America. Police officials have been informed of the trial. Participants will be told they can carry with them small quantities of the study marijuana, but they must also carry a letter explaining their role in the trial. Study organizers don't expect to have any trouble filling the 32 slots. Many people in the HIV/AIDS community regularly use marijuana, said Derek Thaczuk, spokesperson for the Community Research Initiative. "Not everybody cares that there's a lack of scientific evidence," Thaczuk said. "So a lot of people with HIV are using marijuana to reduce their levels of nausea and to increase their food intake to fight weight loss, which can be an extremely serious condition for people with HIV." Thaczuk said he's delighted that the study, which has been several years in the making, is finally underway. "No matter what the issues connected with medical marijuana, it comes back to the fact that we need valid, rigorous scientific data, and that's what we're going to produce." Health Canada's program to investigate marijuana's potential as a medicinal substance was started under former health minister Allan Rock. Some have speculated the current minister, Anne McLellan, is less enthusiastic about the program than her predecessor, but she insists that is not the case. "The minister remains committed to ensuring that we understand the benefits and risks associated with marijuana use for medicinal purposes," her spokesperson, Farah Mohamed, said Wednesday. - --- MAP posted-by: Josh